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The State of Medicine Quality in the Mekong Sub-Region

 | 
Sauwakon Ratanawijitrasin
, 
Souly Phanouvong

4 - The Multiple Requirements of Medicine Quality

Texte intégral

  • 8 For a comprehensive guide on how to ensure a medicine’s quality, readers may refer to ‘United Stat (...)

1Many factors determine medicine quality8. To ensure that good quality medicine reaches the hands of consumers, all the necessary steps in the medicine manufacturing and handling process must be performed in accordance with quality standards. At the starting point, one must ensure that the formulation has the required properties for safety, efficacy and quality, as well as adequate stability for the valid period of use. Then, the quality of all the raw materials, especially active ingredients, must meet the standards. Packaging materials are also important in protecting the medicine from physical damage, and must not interact with any chemical. The packaging materials used must be appropriate for the specific product.

2The structures housing the production and the infrastructures for the production process must be designed properly and be in suitable condition. The production procedures must follow Good Manufacturing Practice (GMP) requirements. Good Laboratory Practice (GLP) is also required for handling the analysis of intermediate and finished products.

3Transportation is a much-overlooked critical stage in the medicine supply chain. The medicine must be kept in conditions preventing deterioration from heat, humidity and other environmental factors in the vehicle during the transportation phase from the suppliers to the various health care settings. A cold chain is needed for certain types of medicines, for example vaccines, which need special care in handling.

  • 9 For example, Yang et al. 2004, Mac et al. 2008

4Storage conditions are crucial to the maintenance of quality. This is especially important for countries with tropical climates such as in the Mekong Subregion. If medicines are not stored in a well-controlled environment, the heat and humidity in those medicine distribution channels can cause deterioration before their expiry date. Many studies on medicine quality implicated storage condition as a major contributing factor leading to the degraded quality9.

5In the five-country study, as well as in the majority of the medicine quality monitoring surveys, samples were collected from the final channel in the manufacturing-distribution chain. Consequently, the quality of medicine can be influenced by the many conditions in the medicine process that came beforehand, as well as by the conditions in which the medicines were kept. Therefore, when a medicine product collected from a distribution channel fails the quality testing, which may be due to degradation during storage, the test result is not always able to pinpoint which factor actually caused the quality problem. This is particularly true for substandard medicines.

Figure 34 : Diagrammatic depiction of the factors in the medicine process critical to quality

Figure 34 : Diagrammatic depiction of the factors in the medicine process critical to quality

Notes

8 For a comprehensive guide on how to ensure a medicine’s quality, readers may refer to ‘United States Pharmacopeia Drug Quality and Information Program and collaborators. 2007. Ensuring the Quality of Medicines in Resource-Limited Countries : An Operational Guide. Rockville, Md. : The United States Pharmacopeial Convention. Available online : http://www.usp.org/pdf/EN/dqi/ensuringQualityOperationalGuide.pdf.

9 For example, Yang et al. 2004, Mac et al. 2008

Table des illustrations

Titre Figure 34 : Diagrammatic depiction of the factors in the medicine process critical to quality
URL http://books.openedition.org/irasec/docannexe/image/1209/img-1.jpg
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